According to the FDA, sub-website Safety Information, Topamax (topiramate), the drug that is used in initial monotherapy for young patients who suffer from tonic-clonic (aka epileptic) seizures, was being recalled.
Topamax was originally manufactured by Ortho-McNeil; the Topamax recall was generated by a “musty” and “unpleasant odor” arising from the medication bottle itself.
The medication, also used in patients over 10 years of age for migraine symptoms, was recalled after four patients complained of the stench, and were forced to stop taking the drug out of fear of side effects.
Topamax Recall due to its Weird Odor
The cause of the odor was apparently the result of trace chemicals found in the wooden storage pallets that shipments of the drug rested on. The recall was described on one end of the spectrum as a necessary step to keep the health of children with epileptic seizures and adults with migraines safe.
On the other hand, some officials considered the plague of odorous medicines a “tempest in a teapot.” With the limited number of complaints, and the unlikely nature of the conditions that caused the complaint, it is probable that the recall did not affect a large number of users.
The fortunate circumstance, most officials agree, is the presence of the telltale odor in the medication that acts as an early warning system for the patient consumer. While officials warned that the contaminated medications should be recalled and destroyed (lots numbered OKG110 or OLG222, expiring in the late summer of 2012), most agreed that if there is no foul odor, the recall does not apply to that particular shipment or those particular bottles.
Adding to the somewhat overly dramatic recall was the fact that the medication being held back was an established pharmaceutical aid to patients suffering from fairly difficult, painful and violent headache and seizure scenarios. In this instance, there was no alternative drug that patients could obtain to ease their suffering or their symptoms.
Most problematic of all was the fact that the Topamax recall prompted further legal action. (see also topiramate side effects)Although Topamax had become established as a drug of choice, it was discovered that its manufacturer, Ortho-McNeil, ran virtually no safety tests on it to determine its efficacy.
In May of 2010, the pharmaceutical company pled guilty to fraud and was ordered to pay restitutions to patients in excess of 6 million dollars. No data exists as to Topamax’s efficacy in treating either seizures or migraine symptoms; although patients reported (in the case of the migraines) a beneficial alleviation of symptoms, it may have been, according to FDA researchers, a placebo effect based upon what the patients were already told about the drug.
If you have concerns about the Topamax recall, consult a reliable medical professional; you are also encouraged to visit online at http://www.abalawinfo.org/ for a free legal consultation.